iFuse TORQ TNT Implant System
FDA 510(k) K241504 · SI-BONE, Inc.
510(k) numberK241504
Submission
- Device name
- iFuse TORQ TNT Implant System
- Applicant
- SI-BONE, Inc.
Santa Clara, CA, US - Received
- May 28, 2024
- Decision date
- August 19, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OUR – Sacroiliac Joint Fixation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
sacroiliac joint fusion
Other 510(k)s with product code OUR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261381 | TiLink-L SI Joint Fusion SystemOUR · Traditional | SurGenTec, LLC | 08/24/2026SE |
| K260477 | CATAMARAN SI Joint Fusion SystemOUR · Traditional | Tenon Medical | 04/08/2026SE |
| K253488 | iFuse INTRA Ti Implant SystemOUR · Traditional | SI-BONE, Inc. | 02/11/2026SE |
| K253611 | Falco Fusion SystemOUR · Traditional | Mcnicoll Surgical, Inc. | 01/29/2026SE |
| K252834 | Sacroiliac Joint Truss System (SJTS)OUR · Traditional | 4Web Medical | 01/28/2026SE |
| K251365 | OptumSI Implant SystemOUR · Traditional | Si Solutions, LLC | 11/20/2025SE |
| K252322 | SIros-X SystemOUR · Traditional | Genesys Spine | 10/22/2025SE |
| K253094 | iFuse Bedrock Granite Implant SystemOUR · Special | SI-BONE, Inc. | 10/09/2025SE |
| K250894 | Eminent Spine Posterior SI SystemOUR · Traditional | Eminent Spine | 10/07/2025SE |
| K250647 | SImmetry+ SystemOUR · Traditional | Sivantage | 07/29/2025SE |
More from Sivantage
| 510(k) | Device | Decision |
|---|---|---|
| K253488 | iFuse INTRA Ti Implant SystemOUR · Traditional | 02/11/2026SE |
| K253094 | iFuse Bedrock Granite Implant SystemOUR · Special | 10/09/2025SE |
| K251780 | iGPS Navigation InstrumentsOLO · Traditional | 09/15/2025SE |
| K241574 | iFuse TORQ® Implant SystemOUR · Special | 07/02/2024SE |
| K232800 | Navigation Tracking InstrumentsOLO · Traditional | 02/23/2024SE |
| K233508 | iFuse Bedrock Granite® Implant SystemOUR · Traditional | 01/26/2024SE |
| K231689 | iFuse TORQ® Implant SystemOUR · Special | 06/30/2023SE |
| K222774 | iFuse Bedrock Granite® Implant SystemOUR · Traditional | 12/22/2022SE |
| K222605 | iFuse TORQ® Implant SystemOUR · Special | 09/29/2022SE |
| K213667 | iFuse-TORQ® Implant SystemOUR · Traditional | 06/10/2022SE |
Questions and answers
When was iFuse TORQ TNT Implant System cleared by the FDA?
iFuse TORQ TNT Implant System (K241504) received a 510(k) decision of Substantially Equivalent on August 19, 2024, 83 days after the submission was received.
What is the product code of K241504?
The FDA product code is OUR – Sacroiliac Joint Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3040.